(UK) "Frenchay to lead 250,000 study into the effects of early intervention for ME"

Frenchay to lead 250,000 study into the effects of early intervention for ME

The UK's biggest research study into whether early intervention could lessen the effects of chronic fatigue syndrome is due to get underway at North Bristol NHS Trust in spring 2012.

Frenchay Hospital is one of only 40 specialist NHS centres in the UK for people with chronic fatigue, also known as ME.

The multi-disciplinary team which includes occupational therapists, physiotherapists and clinical psychologists has been at the forefront of developing techniques around changes in behaviour and using exercise to help patients beat the debilitating illness.

Dr Hazel O'Dowd, the clinical psychologist who runs the centre, said: "People with chronic fatigue feel incredibly isolated. The illness can have a dramatic and long-term effect on their life.

"Since setting up in 2003, we have worked with hundreds of patients to improve their lives. We have particularly focused on cognitive behaviour therapy and graded exercise.

"For example, people with ME have good days and bad. On the good days it is tempting for them to push themselves and then for subsequent days they are so exhausted they can't do anything at all.

"We teach them to pace themselves, just do a little, building up stamina, changing the way they see themselves."

The 250,000 study, which has been funded by the Research for Patient Benefit (RfPB) programme, is a natural progression from the advances made by the Frenchay team.

Dr O'Dowd explains: "Because of the nature of the illness, it can take upwards of four years for clinicians to diagnose ME and during that time people can go rapidly down hill because they are not getting the right treatment."

The trial will involve around 100 patients from a selection of local GP surgeries. Doctors will be asked to identify patients they think might be suitable for the trial. These will be patients who have complained of severe fatigue, and after blood tests, no other reason for their tiredness is found.

50 patients will continue to receive care through their GP and the other 50 will be put in touch with the team at Frenchay who will regularly assess their condition and give advice on how to manage the fatigue.

After the two year trial, both sets of patients will be assessed to see if the early intervention in the one patient group made a significant difference to their overall condition.

Dr O'Dowd said: "This is very much a feasibility study but it will provide clinicians with important information around whether early intervention has positive benefits for these patients. We await the results with interest and would like to thank the Research for Patient Benefit programme for their support with our trial."

A pilot study of the process of change in a group Chronic Fatigue Syndrome management programme. Bulletin of the IACFS/ME. 2009;17(2):53-68

Group interventions based around encouraging CFS patients to increase activity levels have shown modest results. Royle and Pimm (1) state cognitive-behavioural therapy [CBT] and graded exercise therapy [GET] are efficacious therapies in patients with Chronic Fatigue Syndrome (CFS). But is this true for group programmes?

St Bartholomew's Hospital Chronic Fatigue Services (United Kingdom), proponents of CBT and GET programmes for CFS, gave the following summary of the evidence base as part of their submission on the draft NICE Guidelines for CFS/ME (2): The only RCT of CBT using a group approach showed that the treatment was no better than either usual medical care or supportive listening in improving physical function, one of its two primary outcomes, which it was designed to improve (3). A non-randomised waiting list control trial of group delivered CBT found only modest effects on fatigue and negative effects on function (4) to our knowledge, no RCT of group delivered GET has been published, so there is even less evidence to support a group for GET. The results of the (uncontrolled) Royle and Pimm study (1) could perhaps be said to be comparable to the ODowd study, with an improvement in fatigue levels but no statistical improvement in the SF-36 Physical Functioning scores.

ODowd (3) did report improvements in fitness following group CBT, although significance was only reached over Standard Medical Care when 5 outlying observations were omitted. The improvement was modest: at baseline an average of 24.3 shuttles were walked in the 6-minute incremental shuttle walk test. At 6 months and 12 months, the figures were 28.5 and 28.9 respectively. Given ODowd and colleagues report that normative data for healthy controls is an average of 67 shuttles, if one extrapolates the improvement of 0.4 over 6 months in a linear manner, it would take over 47.5 years for the mean number of shuttles for the CFS patients to reach the normal level.

Interventions based on pacing strategies have not been as widely studied as GET and CBT, but positive results with individualised therapy have been reported, including in comparison to interventions which encouraged increasing activity levels (5). Given the fact that CFS is increasingly recognized by researchers as being heterogeneous, and the modest results thus far reported for group interventions based on encouraging all participants to increase activity levels, if group methods are required (for example, due to the cost of individual therapy), perhaps there should now be more focus on programmes based around pacing or the Envelope Theory.

The words Tiredness used, Forget sweating Nausea poisioned weak dizzy lightheaded on and on. Tiredness happens just before i go a kip. the others are a bit more than that. You know many of these reserachers need to live the life for a few years, and then see if tiredness creeps up as a major symptom term from them

Have you ever burst into tears because your too tired ? no didnt think so. Hopefully norway finds out more soon for those desperate for treatment. Funny how i still get tired a lot now, but dont suffer the other symptoms like i did for the first 5 years bad. Thats how much tiredeness should be used as a major symptom here. they really dont look at the worst cases do they. Just the boarderline ones, so it fits there model, that they want it to be. Why oh why are they always downplaying the worst affected paitients, and ignoring the really ill patients.

A pilot study of the process of change in a group Chronic Fatigue Syndrome management programme. Bulletin of the IACFS/ME. 2009;17(2):53-68

Group interventions based around encouraging CFS patients to increase activity levels have shown modest results. Royle and Pimm (1) state cognitive-behavioural therapy [CBT] and graded exercise therapy [GET] are efficacious therapies in patients with Chronic Fatigue Syndrome (CFS). But is this true for group programmes?

St Bartholomew's Hospital Chronic Fatigue Services (United Kingdom), proponents of CBT and GET programmes for CFS, gave the following summary of the evidence base as part of their submission on the draft NICE Guidelines for CFS/ME (2): The only RCT of CBT using a group approach showed that the treatment was no better than either usual medical care or supportive listening in improving physical function, one of its two primary outcomes, which it was designed to improve (3). A non-randomised waiting list control trial of group delivered CBT found only modest effects on fatigue and negative effects on function (4) to our knowledge, no RCT of group delivered GET has been published, so there is even less evidence to support a group for GET. The results of the (uncontrolled) Royle and Pimm study (1) could perhaps be said to be comparable to the ODowd study, with an improvement in fatigue levels but no statistical improvement in the SF-36 Physical Functioning scores.

ODowd (3) did report improvements in fitness following group CBT, although significance was only reached over Standard Medical Care when 5 outlying observations were omitted. The improvement was modest: at baseline an average of 24.3 shuttles were walked in the 6-minute incremental shuttle walk test. At 6 months and 12 months, the figures were 28.5 and 28.9 respectively. Given ODowd and colleagues report that normative data for healthy controls is an average of 67 shuttles, if one extrapolates the improvement of 0.4 over 6 months in a linear manner, it would take over 47.5 years for the mean number of shuttles for the CFS patients to reach the normal level.

Interventions based on pacing strategies have not been as widely studied as GET and CBT, but positive results with individualised therapy have been reported, including in comparison to interventions which encouraged increasing activity levels (5). Given the fact that CFS is increasingly recognized by researchers as being heterogeneous, and the modest results thus far reported for group interventions based on encouraging all participants to increase activity levels, if group methods are required (for example, due to the cost of individual therapy), perhaps there should now be more focus on programmes based around pacing or the Envelope Theory.

"Group CBT did not significantly improve
cognitive function, quality of life (as measured by
the physical subscale of the SF-36), employment
status or healthcare utility measures. However, the
quality of the data obtained for the last item was
too poor to be used in any analysis."

Dr O'Dowd explains: "Because of the nature of the illness, it can take upwards of four years for clinicians to diagnose ME and during that time people can go rapidly down hill because they are not getting the right treatment."

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Maybe they should be researching why on earth it is taking up to FOUR YEARS for people to get diagnosed with something any decent ME specialist could probably diagnose before even the 6mths are up. Does that point to their doctors cant tell the difference between ME and other mental health issues and hence a delayed diagnoses? or are they trying to diagnose those who are hardly really sick???

When I first saw the title of this thread, my first assumption was that they were going to test the outcome of early diagnosis and treatment compared to the typical neglect and dismissal and delayed diagnosis we usually get, although doing so prospectively would be unethical. Instead it turns out to be just another typical CBT/GET trial using tired patients from general practice. Sounds like a slam dunk for them, they have a therapy which convinces patients to score better on subjective measures, the results can be spun despite the lack of objective evidence and issues with case definition.

Yes, perhaps they should research why it is taking so long to even get a diagnosis. I guess for me I was told "nothing was wrong" and that my symptoms were due to "growing pains". Since I was still a relatively "high functioning" teenager at the time, I was ignorant and didn't pursue the issue and just tried to adapt to a normal life which included being seduced by psychobabble and graded exercise, and later CAM out of desperation after a CFS diagnosis. The inevitable failure and declining capabilities and poor quality of life from such an approach were embarrassing incentives to see another doctor again and finally get a diagnosis of "CFS" after at least 6 years of limbo.

I don't blame the first doctor because the CFS construct was new at the time and he probably never heard of it, not to mention back in those days it wasn't supposed to occur in adolescents according to biopsychosocialists! I had some degree of all main symptom categories of CCC-ME/CFS, but I didn't have a major reduction of activity yet (although I struggled to be more than sedentary despite a keenness for exercise and grades were gradually declining) so I don't know if I would have received a CFS diagnosis anyway.

In hindsight the knowledge I have now about ME/CFS would have been invaluable even without treatment. Just knowing that something was indeed "wrong" would have prevented much confusion and self-doubt. Just knowing about the activity ceiling and pacing would have prevented post-exertional suffering and related declines in health. Just knowing that mind over body psychobabble was a useless ideology for CFS would have saved me further declines (although aspects of it was OK for mental health when there was enough energy).

Just knowing that the biopsychosocial approach to CFS is based more on flawed research and speculation than fact would have saved me a few years too. Exercising your way back to health is a dangerous delusion for many patients no matter how careful they are, and now we have to put up with seeing this delusion being perpetrated in medical journals under the guise of pragmatism. Just knowing that the ME/CFS definitions do tend to capture a consistent disease entity would have saved me from looking in the wrong places and wondering why my symptoms aren't described properly by CDC criteria and whether they were even related (after a CFS diagnosis it took me years to realise that it is more than just another way of saying "we don't know" or "it's fatigue in the same category as anxiety and depression").

The internet has been such a great resource for me. I could explore the literature for myself, albeit with limitations. I never heard of ME and reading the Canadian 2003 definition for ME/CFS was a major revelation, it was the first time I felt like anyone knew what they were talking about when it came to the symptoms I experienced. Today I started writing a sarcastic study proposal for the 250,000, about comparing a group of patients subject to the typical neglect and dismissal and delayed diagnosis vs patients receiving proper medical treatment, but I couldn't be bothered finishing it.

Psychiatrists are masters of Human manipulation, THAT is why they have such power and they are like modern day Inquisition:
"If you defy us, you must be mad! Destroy the heretic/madman for opposing us as we do God's Work/aid the poor so do not dare stop us!"

That profession should be destroyed, utterly, it has little to do with scientific-based medicine, has had much to do with gross criminal and unethical behaviour (see revelations in past 5 years regaridng pharma corp ties etc), and is part of the huge psy-ops/corporate world which makes the Soviets etc look like freakin' amateurs.

When I first saw the title of this thread, my first assumption was that they were going to test the outcome of early diagnosis and treatment compared to the typical neglect and dismissal and delayed diagnosis we usually get, although doing so prospectively would be unethical. Instead it turns out to be just another typical CBT/GET trial using tired patients from general practice. Sounds like a slam dunk for them, they have a therapy which convinces patients to score better on subjective measures, the results can be spun despite the lack of objective evidence and issues with case definition.

Yes, perhaps they should research why it is taking so long to even get a diagnosis. I guess for me I was told "nothing was wrong" and that my symptoms were due to "growing pains". Since I was still a relatively "high functioning" teenager at the time, I was ignorant and didn't pursue the issue and just tried to adapt to a normal life which included being seduced by psychobabble and graded exercise, and later CAM out of desperation after a CFS diagnosis. The inevitable failure and declining capabilities and poor quality of life from such an approach were embarrassing incentives to see another doctor again and finally get a diagnosis of "CFS" after at least 6 years of limbo.

I don't blame the first doctor because the CFS construct was new at the time and he probably never heard of it, not to mention back in those days it wasn't supposed to occur in adolescents according to biopsychocialists! I had some degree of all main symptom categories of CCC-ME/CFS, but I didn't have a major reduction of activity yet (although I struggled to be more than sedentary despite a keenness for exercise and grades were gradually declining) so I don't know if I would have received a CFS diagnosis anyway.

In hindsight the knowledge I have now about ME/CFS would have been invaluable even without treatment. Just knowing that something was indeed "wrong" would have prevented much confusion and self-doubt. Just knowing about the activity ceiling and pacing would have prevented post-exertional suffering and related declines in health. Just knowing that mind over body psychobabble was a useless ideology for CFS would have saved me further declines (although aspects of it was OK for mental health when there was enough energy).

Just knowing that the biopsychosocial approach to CFS is based more on flawed research and speculation than fact would have saved me a few years too. Exercising your way back to health is a dangerous delusion for many patients no matter how careful they are, and now we have to put up with seeing this delusion being perpetrated in medical journals under the guise of pragmatism. Just knowing that the ME/CFS definitions do tend to capture a consistent disease entity would have saved me from looking in the wrong places and wondering why my symptoms aren't described properly by CDC criteria and whether they were even related (after a CFS diagnosis it took me years to realise that it is more than just another way of saying "we don't know" or "it's fatigue in the same category as anxiety and depression").

The internet has been such a great resource for me. I could explore the literature for myself, albeit with limitations. I never heard of ME and reading the Canadian 2003 definition for ME/CFS was a major revelation, it was the first time I felt like anyone knew what they were talking about when it came to the symptoms I experienced. Today I started writing a sarcastic study proposal for the 250,000, about comparing a group of patients subject to the typical neglect and dismissal and delayed diagnosis vs patients receiving proper medical treatment, but I couldn't be bothered finishing it.

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Thanks biophile. It took me five years to get diagnosed (and I got ill as a teenager also and was mildly affected for the first few years). A diagnosis would have been useful. That's not the same as any "treatments"/therapies that are associated with it being necessarily beneficial.

After reading this I couldn't get the picture of some overly enthusiastic psychiatrist saying "By God we'll prove that GET And CBT are effective treatments especially when implemented early following it's onset. We'll prove it even if it kills you or incapacitates you whichever one comes first. At which point you will be ejected from the study on the basis of failing to continue with the treatment, being a difficult patient or both."

Just to point out that Dr. O'Dowd is a psychologist with a PhD not a psychiatrist. A psychiatrist is somebody who has a medical degree who then goes on to specialise in psychiatry. Psychologists don't have medical degrees (unless they do!).

Typically of course, pyscologists and therapists that are employed by these ME centres, are cheap and thats why the government uses them. Its a way of pretending to do something for those ill with ME in the UK without actually doing anything real or useful.

The cost of doing something proper, i.e. treating the illness as a pysiological illness and looking at what they can do to treat it (or heaven forbid, asking us what we want them to do!) is far far greater than what they are doing. That is why these places exist, and of course its compatible with their years of neglect of our illness.

I suppose once these people get these jobs and get the centres running they look for ways of getting more funding and the because of the misinformation about ME and the slack requirements for convincing someone to give you some cash for this type of work, they find it fairly easy to get the funding.
Of course, the government can continue to say, "we are doing something" and "we are spending money on research" and the false view of ME in reinforced further.

Cant say i am surprised, but its very annoying. I live fairly close to Frenchay, if they had offered something of value then i could have benefited...

Typically of course, pyscologists and therapists that are employed by these ME centres, are cheap and thats why the government uses them. Its a way of pretending to do something for those ill with ME in the UK without actually doing anything real or useful.

The cost of doing something proper, i.e. treating the illness as a pysiological illness and looking at what they can do to treat it (or heaven forbid, asking us what we want them to do!) is far far greater than what they are doing. That is why these places exist, and of course its compatible with their years of neglect of our illness.

I suppose once these people get these jobs and get the centres running they look for ways of getting more funding and the because of the misinformation about ME and the slack requirements for convincing someone to give you some cash for this type of work, they find it fairly easy to get the funding.
Of course, the government can continue to say, "we are doing something" and "we are spending money on research" and the false view of ME in reinforced further.

Cant say i am surprised, but its very annoying. I live fairly close to Frenchay, if they had offered something of value then i could have benefited...

Dolphin wrote: Thanks biophile. It took me five years to get diagnosed (and I got ill as a teenager also and was mildly affected for the first few years). A diagnosis would have been useful. That's not the same as any "treatments"/therapies that are associated with it being necessarily beneficial.

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Good to know that others had similar experiences of starting out as mild cases and then worsening substantially. Yeah, I'm not sure either if having an earlier diagnosis would have helped treatment, but it hopefully would have prevented management mistakes. How do you think such cases can be diagnosed in time before becoming worse, without either relying on major reductions of activity or making the criteria too broad?

Taking a guess from my own anecdotal experience vs a few other people I knew who had chronic fatigue plus a few other symptoms but never progressed or declined into full blown long term ME/CFS, the difference was not huge differences in initial functional impairments but a tendency for them to not experience the full range of CCC-ME/CFS symptoms in the first place. Another difference was that I never experienced any benefits from exercise. Aerobic exercise seemed to be the worst. I was still able to maintain a sedentary lifestyle and attempt exercise (with negative consequences), but there was a significant reduction of expected capacity beyond sedentariness.

Desdinova wrote: After reading this I couldn't get the picture of some overly enthusiastic psychiatrist saying "By God we'll prove that GET And CBT are effective treatments especially when implemented early following it's onset. We'll prove it even if it kills you or incapacitates you whichever one comes first. At which point you will be ejected from the study on the basis of failing to continue with the treatment, being a difficult patient or both."

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Someone was telling me there was a documentary on TV about experiments 50 years ago that involved reforming prisoners by beating them senseless and subjecting them to tortuous manual labor and stress positions. Turned out these prisoners ended up having a much higher rate of becoming violent offenders upon release. My first response was, "you can almost guarantee there was some psychologist or psychiatrist actively involved in developing that approach, not just being there to monitor the situation". And to borrow a theme from dark humoured friends and movies, there is also a good chance said psychologist or psychiatrist was, on some level, aroused.

Good to know that others had similar experiences of starting out as mild cases and then worsening substantially. Yeah, I'm not sure either if having an earlier diagnosis would have helped treatment, but it hopefully would have prevented management mistakes.

How do you think such cases can be diagnosed in time before becoming worse, without either relying on major reductions of activity or making the criteria too broad?

Taking a guess from my own anecdotal experience vs a few other people I knew who had chronic fatigue plus a few other symptoms but never progressed or declined into full blown long term ME/CFS, the difference was not huge differences in initial functional impairments but a tendency for them to not experience the full range of CCC-ME/CFS symptoms in the first place. Another difference was that I never experienced any benefits from exercise. Aerobic exercise seemed to be the worst. I was still able to maintain a sedentary lifestyle and attempt exercise (with negative consequences), but there was a significant reduction of expected capacity beyond sedentariness.

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I like differentiating between research and clinical criteria, with research criteria being stricter. I don't think anyone has a "right" to be in research - if I had been diagnosed when mild, I wouldn't have minded if I wasn't in research studies. At the same time, it's a serious condition so things should be done to spot people to prevent them becoming more severely affected. So spotting people is important.

I don't have a major answer to your question.

I don't think I had the full range of symptoms when mild e.g. no bladder frequency. I generally didn't have problems with my bowel - (a bit gross) - it maybe became a little looser for the odd stressful event - but many in the population have that sort of level. I don't recall many sore throats for the first four years. I was perhaps unusual as I could be quite sedentary (full time student, no children or other responsibilities) and was generally able to avoid strenuous activities. I seemed to strain muscles when I did so generally I avoid strenuous activities except when doing specific exercise sessions. So I didn't provoke my symptoms which might have been why I wouldn't notice lots of symptoms.

But as an improvement on the current approaches, I think the revised CCC is good:

Meeting research versus clinical criteria

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:
Table 1 provides all the symptoms as specified in the Revised
Canadian ME/CFS case definition. Some meet full
criteria whereas others who are very symptomatic do
not meet full criteria. We argue as we did with the
Pediatric case definition (Jason et al., 2006) that those
that meet full criteria are more homogenous and might
be best used for research purposes and we now classify
these individuals as meeting the Research ME/CFS
criteria. Still, others might have the illness but not meet
one of the required criteria. We classified such
individual as meeting Clinical ME/CFS criteria. These
individuals needed to have six or more months of
fatigue and needed to report symptoms in five out of the
six ME/CFS symptom categories (one of which has to
be post exertional malaise, as it is critical to this case
definition). In addition, for autonomic, neuroendocrine
and immune manifestations, adults must have at least
one symptom in any of these three categories, as
opposed to one symptom from two of the three
categories. We also have a category called Atypical
ME/CFS, which is defined as six or more months of
fatigue, but having two to four ME/CFS symptoms.
There is also a category called ME/CFS-Like, which
involves exhibiting all criteria categories but for a
duration of fewer than 6 months. Further, a person
could be classified as having ME/CFS in remission if
the person had previously been diagnosed with CFS by
a physician but was not currently meeting the Research
ME/CFS Criteria, Clinical ME/CFS criteria, or Atypical
ME/CFS criteria and must have 0 or 1 classic ME/CFS
symptoms.

Another quarter of a mill down the toilet, at the same time as people trying to do geniunely useful research in ME in the UK are blocked by Wessely et al at every turn. I wish I had the energy or money to emigrate

[NB: The research reported here was undertaken at the University of the West of England, Bristol, where
Professor Pheby was Director of the Unit of Applied Epidemiology, and Ms. Saffron was Research Associate
within the Unit]

Abstract

ME/CFS is a serious illness affecting several hundred thousand British people. Some 25% of people with
ME/CFS may be severely ill (housebound or bedbound), sometimes for decades. This observational,
questionnaire-based study was designed to identify risk factors for severe disease. Exposure to potential risk
factors, including familial risks, personality, and early management of the illness, was compared in 124 people
with severe disease and 619 mildly ill controls. Severity was determined by self-report and the Barthel (activities
of daily living) Index. Premorbid personality was assessed using the Neuroticism and Conscientiousness
domains of the IPIP scale. Analysis was by tests of association and logistic regression. Early management of the
illness appeared the most important determinant of severity. Having a mother with ME/CFS was also important.
Smoking and personality were not risk factors, neurotic traits being more frequent among the less severely ill.
Conscientiousness overall was not related to severity

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.

The independent variables in the final model were:
? Occupation
? Problems with social security
? Interval between falling ill and diagnosis
? Perceived value of initial treatment
? Relationship with GP before and after diagnosis
? Involvement of a psychiatrist in initial treatment